Disposable or reusable medical devices in Minimal Invasive Surgery (MIS)

jose 21 March, 2018 3002 No Comments

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Advances in vitreoretinal surgery, and specifically in the minimally invasive surgery, have improved efficiency; consequently, there is an increasing trend toward the performance of retinal surgery in ambulatory surgery centers.1The development of reliable disposal medical devices have led us to re-evaluate our usage of reusable medical devices in small-gauge vitrectomy surgery.1

Why single use?

Choosing between reusable and disposable vitreoretinal medical devices requires weighing many different factors including reliability, fragility, sterility, cost, and number of medical devices needed on hand.2

The key is to strike a balance: limiting reuse to a minimum so as not compromise efficiency and sterility while still being able to provide good eye care to patients who otherwise may not be able to afford the surgery. Only 10% to 15% of patient population can pay the premium cost of vitrectomy.

Surgeon comfort and high-quality tools are essential factors for exemplary outcomes following cataract, retinal or refractive surgery. Having tools that can be trusted to perform consistently each time is key, and some authors consider than the consistency provided by using single-use medical devices often exceeds that of multi-use tools.3

The following factors should be considered when balancing the use of either re-usable or disposable medical devices:

Safety

With the growth of antibiotic-resistant bacteria, there is a continued need for further developments in different types of disinfectant or sterilization methods.4Single use medical devices provide optimal protection against infection and cross contamination for every single surgery.

Special attention must be paid to manipulating neural tissue because of the risk of prion infectious agents causing instrument contamination.2

Certain medical devices used daily in ophthalmic procedures, such as those with a lumen, can be difficult to decontaminate safely. Similarly, scalpel blades and other tools require a consistently sharp, high-precision cutting edge. As such, these items are the most suitable to be replaced with single-use medical devices.3

Time

Time is another intangible factor that is difficult- although not impossible – to quantify.1Providing sterile and ready for use, single-use medical devices save time and improve efficiency ensuring that procedures do not have to be rescheduled due to missing or unsatisfactory medical devices. Time required to properly clean and sterilize microsurgical medical devices is prolonged with the use of reusable medical devices. Time during which a case is stalled while an instrument is replaced can also add up, can be especially important.1

Consistent Quality

The gradual degradation of reusable forceps or scissors can affect the precision of membrane removal or cutting, for example, and ultimately lead to surgical delays and possibly complications that may impact outcomes.2

Fragility

Reusable medical devices degrade over time and require frequent servicing and replacement. The longevity of these medical devices depend on their overall use and how well they are cared for by ophthalmic surgical technician.2

With the gradual movement of vitreoretinal surgery to smaller gauge, the reusable microsurgical medical devices (23-g/25-g) became more difficult to maintain and harder to wash and handle. The smallest alteration in the grasping platform or scissor blades can affect function and slow down operative time.1

Economical

The true cost of reusable medical devices is much more difficult to quantify and predict.2Apparently, the cost (in bulk) of buying single-use medical devices, storing them and constantly replacing them far outweighs that of buying a multi-use instrument. However, the additional costs associated with should be considered. Surgeons must have more than one of each instrument, significantly increasing the initial expenditure on new instrumentation.2 Compared with medical devices used during small-gauge surgery, the repair and maintenance of these larger medical devices was cost efficient.2For example, the costs of sterilizing after every single surgery include the actual sterilization costs and the staffing and transportation costs associated with collecting, packing and moving the tools to a sterilization facility. Furthermore, the cost associated with replacing tools that are damaged and lost during the cleaning process should not be neglected.3

For example, the cost for a vitrectomy in the United States is approximately $3500 to $4000 and in the United Kingdom is around £3500 (about US$5300). In India, the charge is considerably less, around $1500 to $2000. In any of these scenarios, the cost of a disposable surgery pack, at $400 to $500, adds considerably to the expense of the operation.2

Properties

The special composition of the single use medical devices provides outstanding quality and efficient mechanical properties for the intended function of each instrument.

Ecological

Single use medical devices may have a lower environmental impact compared to reusable, thanks to savings on disinfectant chemicals, transportation and energy to reprocess reusable medical devices. Single-use surgical medical devices fall under the legal definition of clinical waste, and must be disposed of in accordance with de National and European Clinical Waste Regulations, which currently mean they go for incineration and landfill, raising concerns as to their environmental impact.5

References

1. Shuler, M. F., Franklin, A., Myers, J. & Gupta, S. Disposable vs Reusable Surgical Instruments : How to Decide ? Which instruments should you choose based on cost and procedure ? Disposable vs Reusable Surgical Instruments : How to Decide ? Which instruments should you choose based on cost and procedure ? 1–5 (2010).
2. Instruments, R. & Financially, M. T. Disposable Instruments are Cost Effective and as Good as Reusable Con : Reusable Equipment.
3. Surgery, O. & Europe, N. Single-use instruments deserve consideration for eye surgery. 14–16 (2016).
4. Prüfungsarbeit, W. The new U . S . FDA regulations on biocompatibility and reprocessing for medical devices. (2017).
5. The Benefits of Sterile Single Use Instruments. Health Care Essentials

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